…while CDER chief rejects claims agency is over-cautious

One of the most senior members of the FDA has presented a stout defence of the agency’s work to the Financial Times. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, told the newspaper that when the FDA rejected new medicines, it did so based on safety and efficacy, not as a result of political pressure or greater conservatism.

She said: "We have a different story from the companies. We understand that [they] have productivity issues but [we] stick to the same safe and effective criteria as our bedrock. Pharma is having a difficult time but we are seeing drugs that have a lot of questions." Ms Woodcock added that the FDA would unveil proposals this autumn on reducing drug development costs by standardising the format and content of clinical trial data. "We need to learn from Henry Ford. Companies collect too much information because they are worried that the FDA will ask for it," she said.

However some drugmakers are adamant that the FDA is too cautious and over-concerned about what the policymakers in Washington think of its efforts. Novartis seems to have all but given up on getting approval in the USA for its new diabetes drug Galvus (vildagliptin), which received the green light in Europe last month, and James Shannon, outgoing head of drug development at the firm, pulled no punches when speaking to the Wall Street Journal.

He said that “the scientists and physicians who are reviewing the products are looking over their shoulder at Capitol Hill”. He added that "I think it results in them taking decisions which are conservative”.

Back to Ms Woodcock who told the FT that FDA staffing and funding, specifically for the inspection of foreign manufacturing sites, remained "thin", and the funding issue was also brought up by the FDA’s Commissioner Andrew von Eschenbach. Speaking at a conference in Washinton, he said that the increase in funding has not kept pace with the agency’s increasing responsibilities. He added that as a result, the FDA “may fail in its mission to protect and promote the health of every American''.

The view that more funding is necessary is backed in most circles but Commissioner Eschenbach has come under fierce criticism from politicians and pressure groups who have claimed that requests for more funds have not been more specific.